Description
Lab Technician (Entry) -Myerstown, PA
This is Full time - 40hrs weekly
Start Time is typically 6am-9am (flexible 1st shift position)
6 month CTH
Main Purpose
Perform standard physical and chemical analysis per the approved procedures, ensuring compliance with the written specifications. This position reports to a QC Manager
in a cGMP laboratory.
Key Tasks & Responsibilities May include, but not limited to:
• Adhere to all aspects of Corporate and Plant safety programs, GMP's, ISO standards or other regulatory requirements.
• Perform or support standard qualitative and quantitative analysis on in-process products, packaging components, bulk and finished products, and stability samples. Perform Dissolution (UV) and USP bottle testing in accordance with the approved testing procedures, the National Formulary (NF), and the United States Pharmacopoeia (USP). Assist with non-compliance investigations as needed.
• Prepare laboratory reagent solutions per the laboratory Kanban system to support testing needs.
• Adhere to all Bayer and Regulatory guidelines for documentation, ensuring accurate, clear, legible and complete records of all information related to the sample login and release, analytical testing and investigations, preventive maintenance and instrument calibration, inventory and training.
o Document test results into the laboratory notebooks, form sheets and the laboratory information management system (i.e. SAP-QM). Report all non-compliance results to supervisor for further evaluation.
o Review and evaluate others documentation and test results for regulatory compliance and against specifications.
•Participate in laboratory safety audits
•Responsible for filing the laboratory documentation and the review of the laboratory documentation prior to filing.
• Assist with the revising of SOPs or testing procedures as needed.
• May perform other duties as assigned, including housekeeping tasks like performing glassware washing and distribution to support the laboratory, processing in-coming laboratory samples.
Key Working Relationships
• Attend daily Level 1 team meetings
•Communicate with other departments when testing, documentation, or scheduling issues arise.
• Routine collaboration with the Quality Assurance staff and Manufacturing department personnel.
Qualifications and Competencies
• At least 2 years of relevant post high school education or experience in the sciences.
Associate/bachelors degree in the science is a plus.
• Must be able to fluently read, write, and speak English; ability to understand verbal and written instructions.
• Must have good organizational skills, high degree of accuracy in testing and completing paperwork, and legible handwriting.
• Must have excellent interpersonal skills and have the ability to work effectively in a team environment.
• Previous experience in good manufacturing practices (GMP) and/or government regulated industry preferred.
• Personal computer (PC) skills a plus.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
